What: Philips HeartStart defibrillator. The HeartStart is an automated external defibrillator that is consist of a “computer with digital interface and.

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Presentation transcript:

What: Philips HeartStart defibrillator. The HeartStart is an automated external defibrillator that is consist of a “computer with digital interface and cartridge containing pads.” 1 Recall Date: April 30, 2008 Why: The On/Off and Shock buttons on the device may stick in place when pressed and so it fail to respond when the button is pressed. This caused a “delay in the delivery of a defibrillation shock when the system advises a shock.” 1 Incidents: The defective was discovered during a testing and there has been no reported incidents during emergency use of HeartStart. Number of Units Sold: 389 When Sold: September Product Recall

Recognition of Problem: The HeartStart Defibrillators was manufactured by Philips in September 2005 and the button sticking in place was discovered during testing. It was found in a very small percentage of the affected units. Speed of Response: The response was slow because there was a three year interval from the time that the defibrillators was manufactured and the recall date. Responsibility: The company made a voluntary recall and contacted consumers to replace the defected product. 2 Management issues

Legal Consequence: It was a voluntary device recall and the government also listed the device for recall. No lawsuits could be found against Philips due to the HeartStart defibrillator defects. Reputation: The incident seems to have little affect on the reputation of Philips because there is no reported incidents. Sales: It cost the company money to replace all the devices that was defected. The government supported trial use of Philips HeartStart defibrillator for a $1,300 device approved for over-the-counter sale. 3 Impact Of Recall

1. Class 2 Recall HeartStart defibrillator. (2010 Nov. 3). U.S. Department of Health & Human Services. Retrieved November 4, 2010, from Feder, Barnaby J. ( 2008, April 2). Study Finds Home Is No Help. The New York Times. 3. Philips Voluntary Device Recall. Philips Sense and Simplicity. Retrieved November 4, from 4. Voluntary Recall for limited number of Philips HeartStart Home Defibrillators (Model M5068A). (2008, May 9). eMedAlert. Retrieved November 4, 2010, from number-of-philips-heartstart-home-defibrillators-model-m5068a-posted /qxc number-of-philips-heartstart-home-defibrillators-model-m5068a-posted /qxc References ETM 591 Joy Duong